SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0320-2021 · 03/15/2021

Class II: Risk

Recall Details

Recall Number: D-0320-2021
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Date Initiated: 03/15/2021
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 91,211 syringes

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

Distribution Pattern

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Class III: Low Risk 11/26/2025

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II: Risk 10/28/2025

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

View all recalls by SUN PHARMACEUTICAL INDUSTRIES INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.